DiagnosUS Pregnancy Test Midstream REF 100-17

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• DiagnosUS Pregnancy Test Midstream REF 100-17

Lot codes and dates

• Model Number100-17
• UDI-DI Code710928980000
• Lot NumbersAll products manufactured
• after March 2021 to includehCG-M11-2103-01 hCG-M11-2105-01

Amount recalled

3,304 tests

This recall covers 27 products

The agency filed one notice per product. You are reading one of them; the other 26 are below.

• One Step Pregnancy Test REF 100-01
• One Step Ovulation Test REF 200-01
• HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10
• HealthyWiser UriTest" UTI Test Strips REF 900-UTI
• HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips
• HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP
• DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
• Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
• To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10
• PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS
• PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips
• PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30…

14 more are in the archive.

Where it was sold

• CA
• FL
• IL
• LA
• NJ
• NY
• TX
• WY

Why it was recalled

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

This product could cause temporary or reversible health problems — stop using it.